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OpenTrials
Completed

NCT Number: NCT03387215

Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NYHA class II-III heart failure
  • Ejection fraction equal to or below 35%
  • On stable heart failure drug treatment

Exclusion criteria

  • Considered medically inappropriate for study participation

Treatment and study plan

ITI-214

Drug

Oral

Placebo

Other

Oral

Primary outcomes

  1. Echocardiogram with Doppler imaging and hemodynamic monitoring

    Time frame: 2 hours

    Cardiac systolic and diastolic function

Secondary outcomes

  1. 12-lead electrocardiogram (ECG)

    Time frame: 2 hours

    Safety and tolerability

  2. Hemodynamic monitoring

    Time frame: 5-6 hours

    Cardiac systolic and diastolic function

  3. Number of patients with treatment-emergent adverse events

    Time frame: 5 days

    Safety and tolerability

Other outcomes

  1. Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers

    Time frame: 2 hours

    Pharmacodynamics

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2018
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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